Open Source

Ralph Barrera/AMERICAN-STATESMAN STAFFChairman and CEO John Simard of Austin-based XBiotech is on the brink of European approval for its drug that is supposed to help people with cancer symptoms and the company is moving full speed ahead with expansion and is opening a new manufacturing facility this month.

BIOTECHNOLOGY

XBiotech is officially told ‘No’ in its effort to gain European approval for its lead cancer drug

Austin-based company says it plans to appeal ruling.

Austin biotech startup XBiotech finally got an answer from European regulatory officials about whether it can sell and market its lead cancer drug, Xilonix, in Europe.

The answer was no.

The company said in a written statement that it plans to request a “re-examination and will have 60 days to submit its grounds for appeal.” The company said it believes it has a “strong position for re-examination.”

XBiotech is focused on treating diseases by identifying antibodies found in people, and then cloning these antibodies for mass production.

Its lead drug, Xilonix, is aimed at treating colorectal cancer by attacking inflammation.

But there has been some controversy over how XBiotech approached its European clinical trials. XBiotech measured symptoms associated with disease progression, such as pain, fatigue and muscle loss.

The company did not use more conventional measures of drug success, such as tumor growth.

Though gaining European approval is important to XBiotech’s survival, the company has other drugs in its development pipeline and is conducting clinical trials in the U.S. for Xilonix.

Simard said during his company’s most recent earnings conference call that XBiotech is conducting a globaly Phase 3 study for Xilonix under a fast-tracked FDA regulatory path. That study is intended to measure overall survival.

News on Open Source is free and unlimited. Access to the rest of 512tech.com comes with an American-Statesman digital subscription, which also includes myStatesman.com and the ePaper edition. Subscribe at statesman.com/subscribe.